Draining bodily fluid

ABSTRACT

A urethral prosthesis with prostatic and bulbar segments connected by two types of ties allows the prosthesis to assume at least two configurations different with inter-segmental distances adapted to situations where the patient either has or does not have normal control of the external sphincter. This is particularly useful for a patient undergoing an anesthetic procedure that affects the external sphincter muscles. When the muscles are anesthetized, the prosthesis may provide constant urine voiding, and when the anesthetic effects wear off, the prosthesis may assume a different configuration to allow the sphincter to reassert control over urinary voiding.

TECHNICAL FIELD

[0001] The invention generally involves urethral prostheses and relatedmethods for draining bodily fluid from a patient.

BACKGROUND INFORMATION

[0002] Normal voiding of urine can be controlled through a patient'ssphincter muscles, including voluntary control through the externalsphincter. When functions of sphincter muscles are temporarilycompromised, for example, due to anesthesia, a patient's control overnormal urine voiding is likewise temporarily compromised.

[0003] Medical professionals that treat patients undergoing ananesthetic procedure currently have limited options for addressingurinary retention during and after the procedure. These include the useof a Foley catheter. In many cases, because post-operation assistance invoiding is needed (such as in the case of a urethral stenosis), theFoley catheter will remain in the patient's urethra. However, there aredisadvantages in the use of a Foley catheter after an anestheticprocedure. For example, because the Foley catheter provides constantdrainage through the urethra by maintaining the internal sphincter open,it does not allow the patient to control voiding even after the patientrecovers normal sphincter function. This has brought inconvenience andemotional distress to the patient. Also, the Foley catheter extendsoutside the body, again causing the patient emotional distress anddiscomfort. The extracorporeal portion of the Foley catheter alsosubjects the patient to risks of infection.

SUMMARY OF THE INVENTION

[0004] It is an object of the invention to provide a patient (e.g., ahuman male) with assisted urinary voiding, while also allowing thepatient to control the external sphincter muscle as it regainsfunctionality, such as after an anesthetic procedure. It is anotherobject of the invention to provide the patient with such assisted andcontrollable release without the discomfort, emotional distress, orinfection rates associated with conventional treatments.

[0005] In one aspect, the invention relates to a urethral prosthesiscapable of adopting at least two configurations depending on thefunctioning or non-functioning of a patient's external sphinctermuscles. When the external sphincter muscles are not functioning ormalfunctioning, the prosthesis may assume a compact configuration(locked or tied), and be placed in the urethra and adjacent the externalsphincter muscles to provide constant drainage. When the externalsphincter regains its function, the prosthesis may be transformed intoan extended configuration. Reconfiguration will allow reposition ofportions of the prosthesis away from the external sphincter muscles sothat the muscles can contract and control urinary voiding.

[0006] An embodiment in accordance with these aspects of the inventionincludes a first segment, a second segment, and an adjustable tieconnecting the two segments. The first segment includes a distal portionwith at least one distal opening for receiving fluids such as urine, anda proximal portion with at least one proximal opening. A lumen extendsfrom the at least one distal opening to the at least one proximalopening. The second segment similarly includes a distal portion, aproximal portion, and a lumen extending from at least one distal openingto at least one proximal opening. The connecting tie is adjustable witha variety of inter-segmental lengths; such adjustments result in avariety of corresponding distances between the segments. The tie may beadjusted to shorten the distance between the segments so that theproximal portion of the first segment directly contacts the distalportion of the second segment. This “compact” configuration of theprosthesis is useful when patient's external sphincter is malfunctioningbecause the sphincter muscles may be held open by the prosthesis,resulting in constant drainage. When the external sphincter regains itsfunction and voluntary control over the assisted voiding is desired, theprosthesis can be adjusted to assume an “extended” configuration. To doso, the inter-segmental distance is lengthened to allow insertion of anobject, such as a portion of the external sphincter, which interceptsfluid communication between the lumens of the two segments. Under thisextended configuration, the prosthesis permits functional sphinctermuscles to contract and block, or extend and open fluid communicationbetween the lumens, and therefore, achieving voluntary control overassisted urine voiding.

[0007] The adjustable tie in this embodiment may comprise a thread withtwo-ends. The ends may be connected or unconnected. In a preferredembodiment, the thread forms at least one loop between the proximalportion of the first segment and the distal portion of the secondsegment. In a particularly preferred embodiment, the thread forms aone-and-a half loop between the segments. The ends of the thread may beknotted together. Upon pulling the knot in a substantially proximaldirection, the tie tightens the connection between the two segments,i.e., it shortens the inter-segmental distance.

[0008] The prosthesis, in accordance with another aspect of theinvention, may further include a second tie connecting the proximalportion of the first segment and the distal portion of the secondsegment. This second tie has a pre-determined inter-segmental lengthbetween the first and the second segments of the prosthesis. Thepre-determined inter-segmental length in turn sets the maximum value forthe distance between the first and the second segments of theprosthesis. Such a maximum inter-segmental distance may be sufficientfor the insertion of at least a portion of the functional externalsphincter to effect voluntary control over fluid drainage. To reach thismaximum inter-segmental distance, a retrieval piece may be connected tothe proximal portion of the second segment. This retrieval piece may bea thread that can be pulled upon to help adjust the distance between theprosthetic segments, e.g., by pulling substantially away from the firstprosthetic segment. Furthermore, a third segment may be removablyconnected to the proximal portion of the second segment. The thirdsegment includes a distal portion, a proximal portion, and a lumenextending from at least one distal opening to at least one proximalopening. Fluid flowing from the lumens of the first and second segmentcan be relayed through the lumen of the third segment and emptied into adrainage bag connected to the proximal portion of the third segment.

[0009] An embodiment according to another aspect of the inventionincludes a first and a second segments similar to the ones describedabove. At least two ties connect the segments. The first tie engages thetwo segments by holding the two segments close enough to allow fluidcommunication between the lumens of the segments. In a preferredembodiment, the first tie holds the proximal portion of the firstsegment in direct contact with the distal portion of the second segment.The second tie connects the two prosthetic segments together at aninter-segmental distance upon disengagement of the first tie. Thisinter-segmental distance may be long enough to permit bodily control offluid communication between the tubular lumens (e.g., insertion ofportions of a sphincter muscle). Again, a retrieval piece may beconnected to the proximal portion of the second segment. This retrievalpiece may be a thread that can be pulled upon to help increase thedistance between the prosthetic segments. Furthermore, a third segmentwith a lumen may be removably connected to the proximal portion of thesecond segment. Again, fluid flowing from the lumens of the first andsecond segment can be relayed through the lumen of the third segment andemptied into a further connected drainage bag.

[0010] Embodiments of the invention may include additional features. Forinstance, the first segment may incorporate an inflatable balloon. Theballoon may be used for proper placement of the prosthesis. The distalportion of the first segment may further comprise a coudé tip. The firstand second tubular segments are preferably made of a biocompatiblematerial, such as silicone.

[0011] A method is provided for draining bodily fluid from a patient. Aprosthesis having two connected segments is inserted into the urethra ofa patient, then the distance between the segments is adjusted inresponse to sphincter functionality. When the patient has temporarilylost his sphincter function, the distance between the two segments maybe shortened to allow fluid communication between the lumens of theprosthetic segments. When the patient regains sphincter function, thetwo segments of the prosthesis can be adjusted further apart to allowthe sphincter muscles to come in between the two segments. A prosthesiswith an adjustable tie as described above is useful for these purposes.The prosthesis may include a retrieval piece connected to the secondsegment. Pulling the retrieval piece substantially away from the firstsegment may help lengthen the inter-segmental distance, while pullingboth ends of the adjustable tie shortens the inter-segmental distance.Furthermore, a second tie may be also provided to connect the proximalportion of the first segment with the distal portion of the secondsegment. The second tie connects the two segments at a distance fromeach other, limited by a pre-determined length. This pre-determinedinter-segmental distance may be long enough to allow the patient'ssphincter muscles to come in between the two segments and controlvoiding.

[0012] Another method is provided for draining bodily fluid from apatient. A prosthesis having two segments is inserted into the urethraof a patient, and the two segments are connected by at least two ties.The first tie engages the two segments by holding the two segments closeenough to allow fluid communication between the lumens of the segments.The second tie has a longer inter-segmental length. When the first tieis engaged, constant drainage is provided. However, when sphinctercontrol over urine voiding is desired, the first tie is disengaged fromthe prosthesis and/or removed from the urethra while at least a portionof the prosthesis remains in the urethra. And the second segment may bepulled away from the first segment through a retrieval piece attached tothe second segment, increasing the inter-segmental distance. Because thefirst tie is disengaged, only the second tie is holding the tubularsegments together, and its inter-segmental length determines thedistance between the prosthetic segments. This distance may be longenough for the sphincter muscles to assert control over fluidcommunication between the lumens.

[0013] The foregoing and other objects, aspects, features, andadvantages of the invention will become more apparent from the followingdescription including drawings and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] In the drawings, like reference characters generally refer to thesame parts throughout the different views. Also, the drawings are notnecessarily to scale, emphasis instead generally being placed uponillustrating the principles of the invention.

[0015]FIG. 1 is a schematic view of one embodiment of a prosthesisaccording to the invention.

[0016]FIG. 2a illustrates the prosthesis of FIG. 1 in a first andcompact configuration inside the urethra of a patient.

[0017]FIG. 2b illustrates the prosthesis of FIG. 1 in a second andextended configuration inside the urethra of a patient.

[0018]FIG. 3 illustrates certain features of one disclosed embodiment ofa urethral prosthesis according to the invention.

[0019]FIG. 4 illustrates a method of using some of the features shown inFIG. 3 to assist placement of a urethral prosthesis inside a patient'surethra.

[0020]FIG. 5 shows a first and compact configuration of anotherembodiment of a prosthesis according to the invention.

[0021]FIG. 6 shows a second and extended configuration of the prosthesisof FIG. 5.

[0022]FIG. 7 illustrates an embodiment of a part of the prosthesis shownin FIG. 5.

DESCRIPTION

[0023] The invention involves a urethral prosthesis for providing reliefof urinary retention, and to related methods. Specifically, theinvention provides devices and methods for assisting urinary releaseunder different physiological conditions, namely, the functioning ornonfunctioning of a patient's sphincter muscles in relation tocontrolling urinary release. The invention provides prostheses that eachhas at least two configurations adapted for the different conditions ofthe sphincter muscles.

[0024] An embodiment of a urethral prosthesis of the invention for usein treating urinary retention is illustrated in FIG. 1. A prosthesis 9includes a first segment 10 and a second segment 20, connected by atleast one adjustable tie 5. Both segments may assume a variety ofshapes, such as cylindrical, conical, or a combination of variousshapes, formed by an outer surface and a lumen surface that may besmooth, ridged or pleated. The segments may have cross sections that areof any shape capable of maintaining an orifice open, including but notlimited to the following geometric forms: circular, oval, elliptical, orcrescent. Each segment's cross section may further change through itslength in terms of size or shape. The segments 10 and 20 may be composedof any biocompatible material, such as silicone, PTFE, polyurethane, andso on. The first tubular segment 10 has a distal portion 11 and aproximal portion 19, and is sometimes termed the “prostatic segment” asit is designed to reside in the prostatic section of the urethra whenplaced properly in the urethra. The distal direction, as used in thisapplication, is from the perspective of an operator, and therefore, whenthe prosthesis is inserted into the urethra of a patient, its distalportion points into the patient's body. The distal portion 11 of thefirst segment 10 may be straight, rounded, or may assume the shape of acoudé tip (a closed and curved tip, e.g., with a bent of about 40 degreeangle) for ease of placement inside the urethra. A coudé tip is wellknown in the art, and is described in literatures such as U.S. Pat. Ser.No. 4,292,270 to Hannah et al., incorporated herein by reference. Thedistal portion 11 has at least one opening 2 for receiving bodily fluidssuch as urine once inserted into the urethra or further up into thebladder. The opening 2 may be located at the distal tip or any otherpart of the distal portion 11 as long as the opening 2 can receive urineonce properly positioned. A proximal opening 42 is located at theproximal portion 19, preferably the proximal end. A lumen extends fromthe distal opening 2 to the proximal opening 42.

[0025] The second segment 20 is sometimes termed the “bulbar segment” asit is designed to reside in the bulbar section of the urethra when theprosthesis 9 is placed properly in the patient's urethra. It also has adistal portion 21 and a proximal portion 29. A lumen also extendsthrough the second segment 20 from a distal opening 46 in the distalportion 21, preferably at the distal end, to a proximal opening 48 inthe proximal portion, preferably at the proximal end.

[0026] The adjustable tie 5 connects the proximal portion 19 of thesegment 10 with the distal portion 21 of the segment 20. The tie 5 maybe a thread, a ribbon, a cord, a wire, a tape, a line, or the like, thatengages, unites, links or holds the two prosthetic segments together.The tie 5 can be made of strands of a polymeric material, of silicone,metal, plastic, or rubber. The tie 5 may also be braided or amonofilament. By adjusting the tie 5, an inter-segmental distance 4between the proximal portion 19 of segment 10 and the distal portion 21of segment 20 can be varied. In one embodiment, the adjustable tie 5 isa thread or a medical-grade suture wire that has two ends 6 and 7. Thetwo ends may be tied together or otherwise connected, or not connectedat all. The tie 5 may be adjusted through a variety of mechanisms. FIG.1 illustrates one possible mechanism where the tie 5 forms at least onecomplete loop between portion 19 and portion 21. More specifically, thetie 5 shown in FIG. 1 forms a one-and-half loop as the two ends 6 and 7are not connected here. The tie 5 may be of a sufficient length thatboth ends 6 and 7 extend outside the patient's body when the prosthesisis in use. If the ends 6 and 7 are connected, the tie 5 forms two loopsof differing sizes between the portion 19 and portion 21. The smallerloop 14 controls the inter-segmental distance 4 and the larger loop 85may be partly outside a patient's body for extracorporeal manipulationduring use.

[0027] In the particular embodiment illustrated in FIG. 1 where the twoends are not connected, pulling both ends 6 and 7 will shrink thesmaller loop 14 connecting portion 19 and portion 21, effectivelyshortening the inter-segmental distance 4. When the two ends areconnected at a knot, the inter-segmental distance 4 can similarly beshortened by pulling the knot or both sides of the knot toward the knot.In a preferred compact configuration, the adjustable tie 5 is tightenedto its foremost, and the proximal portion of the first segment directlycontacts the distal portion of the second segment. The two lumens are inclose alignment and the inter-segmental distance 4 essentially becomesnull. The inter-segmental distance 4 can also be lengthened. Onemechanism to lengthen the distance 4 is shown in FIG. 1, in which atleast one retrieval piece 25 is attached to segment 20, preferably toits proximal portion 29, and the smaller loop 14 of the tie 5 isenlarged by pulling the retrieval piece 25 substantially away from thefirst segment 10. The retrieval piece 25 may be a thread, a ribbon, awire, a tape, a suture, or the like, and may be made of similar materialas the adjustable tie 5.

[0028] At least one second tie 18 may also connect the proximal portion19 of the segment 10 and the distal portion 21 of the segment 20. Likethe adjustable tie 5, the second tie 18 may be a thread, a ribbon, acord, a wire, a tape, a line, or the like, that engages, unites, linksor holds the two prosthetic segments together. The second tie 18 mayalso be made of similar materials as the tie 5. The second tie 18 has apre-determined inter-segmental length, i.e., the length of the secondtie 18 between the two prosthetic segments, once the second tie 18 isfully extended, is fixed. In the particular embodiment shown in FIG. 1,the second tie 18 is fixedly fastened to the first segment 10 at point31, and to the second segment 20 at point 32. Because the second tie 18is fixedly fastened at both ends in this case, its length between thefirst and second prosthetic segments 10 and 20, i.e., itsinter-segmental length, is pre-determined. When the second tie 18 isfully extended, its inter-segmental length becomes the inter-segmentaldistance 4. In the particular embodiment shown in FIG. 1, as the segment20 is pulled away from the segment 10 by the retrieval piece 25, theinter-segmental distance 4 gradually increases until stopped by afully-extended second tie 18. Therefore, the inter-segmental length ofthe second tie 18 sets the maximum value for the inter-segmentaldistance 4. However, the invention also contemplates using otherstructures known to a skilled artisan to set the maximum value of theinter-segmental distance 4. One example is to use a closed loop betweenthe segments 10 and 20 as shown in FIG. 6 in which the loop engages thetwo prosthetic segments at points 31 and 32 and the second tie 44 may beable to slide through the points 31 and 32. There may also be multipleadjustable ties 5 and multiple second ties 18 in a prosthesis 9connecting the two segments 10 and 20.

[0029]FIGS. 2a-2 b illustrate how the embodiment of FIG. 1 can be usedto assist urinary voiding. The prosthesis 9 is inserted, through thepenile urethra, further up into the urethra of a patient, until thedistal portion 11 of the prostatic segment 10 is disposed in the bladder50 where the distal opening 2 can receive urine. Proper positioning ofthe prosthesis can be confirmed through a cystoscope or other means, oneof which will be discussed later in association with FIGS. 3-4. Onceproperly positioned, a portion of the prostatic segment 10 should beinside the prostatic urethra, which is adjacent to a prostate 60. Theconnection between the prostatic segment 10 and the bulbar segment 20should be adjacent to an external urinary sphincter 70. When normalsphincter function is compromised, such as when the patient is underanesthesia, the inter-segmental distance 4 between segments 10 and 20 isshortened, through ways described in association with FIG. 1. Asparticularly shown in FIG. 2a, the adjustable tie 5 connects the firstand second segments 10 and 20 of the prosthesis 9 in two loops, as thetwo ends of the tie 5 are connected at a knot 16. Upon pulling the knot16 substantially away from the first segment 10, the smaller loop formedby tie 5 gets tightened, bringing the two segments close enough to allowconstant fluid communication between their lumens. Under this compactconfiguration, the prosthesis holds the urethra and the externalsphincter muscles 70 open, thereby providing constant urine drainagethrough the aligned lumens.

[0030] When the patient regains voluntary control over the externalsphincter 70, such as when the effects of anesthesia wears off, anextended configuration of the prosthesis may be used to allow voluntarycontrol over urine voiding. As shown in FIG. 2b, the inter-segmentaldistance 4 between the prostatic segment 10 and bulbar segment 20 islengthened, allowing the insertion of the external sphincter 70. If theprosthesis 9 is in the compact configuration depicted in FIG. 2a, anoperator may transform the prosthesis 9 into an extended configurationby increasing the distance between the segments 10 and 20. The operatormay pull the retrieval piece 25, attached to the proximal portion of thebulbar segment 20, substantially away from the prostatic segment 10,until stopped by the second tie 18. In this case, the inter-segmentaldistance 4 increases toward its maximum value set by the second tie 18that connects the two segments. Since the extended configuration doesnot rely on the adjustable tie, the adjustable tie may be cut loose, ifknotted, and/or removed from the urethra while at least a portion of theprosthesis 9 remains inside the urethra. The removal can be achieved bysimply pulling one loose end of the adjustable tie 5 out of the urethra.The rest of the tie 5 will follow. Under this extended configuration,the distance between the prostatic segment 10 and bulbar segment 20 maybe designed to be long enough for the sphincter muscles 70 to contractbetween the two tubular segments and intercept or block fluid flowbetween the lumens of the segments 10 and 20.

[0031] The methods provided here are particularly useful for patientswhose external sphincter function is temporarily compromised, as in thesituation of undergoing an anesthetic procedure that affects thesphincter muscles. When the sphincter is under the influence ofanesthesia, the prosthesis may assume a compact configuration, such asone depicted in FIG. 2a, to provide constant urine drainage. When theeffect of anesthesia is wearing off, the prosthesis may be transformedinto an extended configuration, such as one depicted in FIG. 2b, toallow voluntary control over urine voiding through the externalsphincter. There may be a variety of reasons why the patient needs theassistance of a urinary prosthesis, such as in the situation of havingenlarged prostate 60, which obstructs the prostatic urethra. By using aprosthesis described here, the patient has the ability to controlassisted voiding as soon as his external sphincter regains its function.

[0032] A collecting device such as a condom catheter may be placedaround the patient's penis for receiving drained fluid. Since the bulbarsegment typically does not extend outside the patient's body, and onlythe ties and the retrieval piece extend that far, the risk of infectionis minimized.

[0033]FIG. 3 shows some additional features that may be incorporatedinto various embodiments of the invention. The prostatic segment 10 mayinclude an inflatable balloon 1 connected through a tube 3 to aninflation source 8 that can introduce fluid (e.g., air, saline fluid)into tube 3. The tube 3 may be made of a flexible material. In theparticular embodiment shown in FIG. 3, the inflation source is a syringewith a check valve 22. Once the balloon 1 is inflated, the check valve22 (or a one-way valve) ensures that the balloon stay inflated bystopping fluid from flowing back. Other auxiliary structures, such as amalecot, that can be enlarged from outside the patient's body once theprosthesis is inserted into the urethra are also contemplated to beuseful here.

[0034] The balloon or its equivalent structure can be used to confirmproper placement of the prosthesis. Referring to FIG. 4, first, theprosthesis is inserted high up the urethra where the balloon portionmost likely enters the bladder 50. Then a volume of fluid is deliveredthrough the tube 3 to inflate the balloon 1. And the operator pulls onthe retrieval piece 25 to withdraw the prosthesis until resistance isfelt, meaning that the inflated balloon 1 has been stopped by thebladder neck 51. The prosthesis is designed so that the portion from theballoon to the proximal end of the prostatic segment 10 corresponds tothe length of the prostatic urethra—once the balloon hits the bladderneck, the connection between the prostatic segment and the bulbarsegment is substantially adjacent to the sphincter muscles 70. Thismeans of confirming the proper placement of a urinary prosthesis doesnot require the use of a cystoscope, permitting a general practitioneror other medical staff to perform this procedure.

[0035] A third tubular segment may optionally be attached proximally tothe bulbar segment. The third segment contains a lumen aligned with thelumen of the bulbar segment. The third segment may be removablyconnected to the bulbar segment (e.g. using an adjustable tie similar tothe one used to connect the prostatic segment with the bulbar segment).The third segment may be long enough to extend outside the patient'sbody during use. A drainage bag may be connected to the proximal portionof the prosthesis (e.g., the proximal portion of the third segment) tocollect drained fluid.

[0036] A further embodiment of the invention is illustrated in FIGS.5-6. A prostatic segment 10 and a bulbar segment 20 similar to the onesdescribed earlier are connected by at least one first tie 33 and atleast one second tie 44. Both ties may be a thread, a ribbon, a cord, awire, a tape, a line or the like, that engages, unites, links or holdsthe two prosthetic segments together. The first tie 33 engages the twosegments by holding them in close proximity to allow fluid communicationbetween the lumens of the segments 10 and 20. The second tie 44 connectsthe two segments with a pre-determined inter-segmental length. In apreferred embodiment, the first tie 33 holds the proximal portion 19 ofthe segment 10 in direct contact with the distal portion 21 of thesegment 20. The second tie 44 may be fixedly fastened, at both ends, tothe prosthesis, as shown in FIGS. 5-6. Or, as also shown in FIG. 6, thesecond tie 44 may be a closed loop between the segments 10 and 20, andat points 31 and 32 where the second tie 44 engages the prosthesis, thesecond tie 44 may be able to slide through the points 31 and 32. If thefirst tie 33 is disengaged from the prosthesis, as shown in FIG. 6, thesegment 10 is connected to the segment 20 at a longer inter-segmentaldistance that is now limited by the second tie 44.

[0037]FIG. 7 illustrates the details of a preferred embodiment of thefirst tie 33 shown in FIG. 5. The first tie 33 forms a closed loopbetween the prostatic segment 10 and the bulbar segment 20. At junction66, a tape portion 35 of the first tie 33 extends out. The junction 66can adopt a variety of geometric shapes. As shown in FIG. 7, thejunction 66 assumes a “T” shape. Alternatively, the junction 66 canadopt a “Y” shape or other suitable shapes. Two perforated lines travelthroughout the length of the tape portion 35, dividing the tape portion35 into three longitudinal sections. A middle section 37 is furtherconnected to an actuation thread 77 at junction 66. The actuation thread77 may be of a length that, once the prosthesis is properly positionedinside the patient, the thread 77's end 76, which is opposite thejunction 66, extends outside the patient's body. When the end 76 of theactuation thread 77 is pulled with enough strength, the perforated linesin the tape portion 35 will tear, starting from junction 66, all the wayalong the tape portion 35. Consequently, the middle section 37 is tornaway, effectively disconnecting the loop formed by the first tie 33.Optionally, the tape section 35 itself may be long enough to extendoutside the patient's body during use, and once the loop of the firsttie 33 is disconnected at the junction 66 by pulling the actuationthread 77, the rest of the loop may be removed from the urethra bysimply pulling on the rest of the tape section 35.

[0038] To drain bodily fluid from a patient, the embodiment illustratedin FIGS. 5-7 is first inserted into the urethra of a patient. Properplacement may be confirmed, for example, through the inflated balloon inthe prostatic segment. The prosthesis may be inserted in a compactconfiguration where the prostatic segment 10 and the bulbar segment 20are held close enough, by the first tie 33, to allow fluid communicationbetween the lumens of the prosthesis. In the situation where patient isunder anesthesia, the compact configuration provides constant urinarydrainage for the patient. When the effect of anesthesia wears off, andthe patient regains sphincter function, an operator can pull on theextra-corporeal end 76 of the actuation thread 77, disconnecting thefirst tie 33 at junction 66, as described above in connection with FIG.7. Once the first tie 33 is disconnected, the operator may pull on theretrieval piece 25 connected to the proximal portion 29 of the bulbarsegment 20 to further separate the two segments into an extendedconfiguration. The second tie 44 now determines the maximum length ofthe inter-segmental distance, which may be designed to allow thesphincter muscles to contract between the two prosthetic segments and tointercept or block fluid communication between the lumens of thesegments.

[0039] The invention contemplates the combination of the prosthesis asdescribed above with other auxiliary devices used during treatment orsurgical procedure of the urinary tract such as treating urinaryretention. The use of the prosthesis may be combined with an insertionsleeve, a pusher, a stylet, an endoscope, and so on. A pusher may beused to advance the prosthesis up the urethra and into the bladder. Astylet may reside within the lumens of both the prostatic segment andthe bulbar segment to maintain the overall connection between thesegments, especially in the extended configuration.

[0040] Variations, modifications, and other implementations of what isdescribed herein will occur to those of ordinary skill in the artwithout departing from the spirit and the scope of the invention asclaimed. Accordingly, the invention is to be defined not by thepreceding illustrative description but instead by the spirit and scopeof the following claims.

What is claimed is:
 1. A prosthesis for insertion into a patient'surethra, comprising: (a) a first segment including a distal portion anda proximal portion, the distal portion comprising a distal opening, theproximal portion comprising a proximal opening, the first segmentdefining a lumen extending from the distal opening to the proximalopening; (b) a second segment connected to the first segment at aninter-segmental distance, the second segment including a distal portionand a proximal portion, the distal portion of the second segmentcomprising a distal opening, the proximal portion of the second segmentcomprising a proximal opening, the second segment defining a lumenextending from the distal opening of the second segment to the proximalopening of the second segment; and (c) a tie connecting the proximalportion of the first segment and the distal portion of the secondsegment, wherein the tie adopts one of a plurality of configurations inwhich the tie has one of a plurality of inter-segmental lengths betweenthe first and second segments, positioning the first and second segmentsat one of a plurality of inter-segmental distances.
 2. The prosthesis ofclaim 1, wherein the tie is adjustable to adopt a compact configuration,positioning the proximal portion of the first segment in direct contactwith the distal portion of the second segment.
 3. The prosthesis ofclaim 1, wherein the tie is adjustable to adopt an extendedconfiguration, in which the inter-segmental distance permits insertionof an object between the two segments such that the object interceptsfluid communication between the lumens of the first and second segments.4. The prosthesis of claim 3, wherein the inter-segmental distancepermits operation of an external sphincter muscle.
 5. The prosthesis ofclaim 1, wherein the tie comprises a thread with two ends.
 6. Theprosthesis of claim 5, wherein the two ends of the thread are connected.7. The prosthesis of claim 5, wherein the two ends of the thread are notconnected.
 8. The prosthesis of claim 5, wherein the thread forms atleast one loop between the proximal portion of the first segment and thedistal portion of the second segment.
 9. The prosthesis of claim 8,wherein the thread forms a one-and-a-half loop between the proximalportion of the first segment and the distal portion of the secondsegment.
 10. The prosthesis of claim 6, wherein the ends of the threadare knotted together.
 11. The prosthesis of claim 1, further comprisinga second tie also connecting the proximal portion of the first segmentwith the distal portion of the second segment, the second tie having apre-determined inter-segmental length between the first and secondsegments, the pre-determined inter-segmental length setting a maximumvalue for the plurality of inter-segmental distances.
 12. The prosthesisof claim 11, wherein the maximum value for the plurality ofinter-segmental distances permits insertion of an object between the twosegments such that the object intercepts fluid communication between thelumens of the first and second segments.
 13. The prosthesis of claim 12,wherein the maximum value for the plurality of inter-segmental distancespermits operation of an external sphincter muscle.
 14. The prosthesis ofclaim 1, wherein the first segment further comprises an inflatableballoon.
 15. The prosthesis of claim 1, wherein the distal portion ofthe first segment further comprises a coudé tip.
 16. The prosthesis ofclaim 1, wherein the first and second segments comprise a biocompatiblematerial.
 17. The prosthesis of claim 16, wherein the biocompatiblematerial comprises silicone.
 18. The prosthesis of claim 1, furthercomprising a retrieval piece connected to the second segment.
 19. Theprosthesis of claim 18, wherein the retrieval piece comprises a thread.20. The prosthesis of claim 1, further comprising a third segmentincluding a distal portion comprising a distal opening, and a proximalportion comprising a proximal opening, the third segment defining alumen extending from the distal portion of the third segment to theproximal portion of the third segment, the distal portion of the thirdsegment being removably connected to the proximal portion of the secondsegment.
 21. The prosthesis of claim 20, wherein the proximal portion ofthe third segment is connected to a drainage bag for collecting fluidpassing through the lumen of the third segment.
 22. A prosthesis forinsertion into a patient's urethra, comprising: (a) a first segmentincluding a distal portion and a proximal portion, the distal portioncomprising a distal opening, the proximal portion comprising a proximalopening, the first segment defining a lumen extending from the distalopening to the proximal opening; (b) a second segment connected to thefirst segment at an inter-segmental distance, the second segmentincluding a distal portion and a proximal portion, the distal portion ofthe second segment comprising a distal opening, the proximal portion ofthe second segment comprising a proximal opening, the second segmentdefining a lumen extending from the distal opening of the second segmentto the proximal opening of the second segment; (c) a first tie engagingthe first and the second segments by holding the segments in proximityto allow fluid communication between the lumens of the segments; and (d)a second tie having a predetermined inter-segmental length between thefirst and the second segments, the second tie connecting the proximalportion of the first segment and the distal portion of the secondsegment at an inter-segmental distance upon disengagedment of the firsttie.
 23. The prosthesis of claim 22, wherein the first tie holds theproximal portion of the first segment in direct contact with the distalportion of the second segment.
 24. The prosthesis of claim 22, whereinthe inter-segmental distance permits insertion of an object between thetwo segments such that the object intercepts fluid communication betweenthe lumens of the first and second segments.
 25. The prosthesis of claim24, wherein the inter-segmental distance permits operation of anexternal sphincter muscle.
 26. The prosthesis of claim 22, furthercomprising a third segment including a distal portion and a proximalportion, the distal portion of the third segment comprising a distalopening, the proximal portion of the third segment comprising a proximalopening, the third segment defining a lumen extending from the distalopening of the third segment to the proximal opening of the thirdsegment, the distal portion of the third segment removably connected tothe proximal portion of the second segment.
 27. The prosthesis of claim22, wherein the proximal portion of the third segment is connected to adrainage bag for collecting fluid passing through the lumen of the thirdsegment.
 28. The prosthesis of claim 22, wherein the first tie comprisesa loop connecting the first and second segments, a tape and an actuationthread, all connected at a junction.
 29. The prosthesis of claim 28,wherein the tape comprises a perforated portion connected to theactuation thread at the junction, wherein the perforated portion tearsfrom the tape upon pulling the actuation thread.
 30. The prosthesis ofclaim 22, wherein the second tie comprises a thread.
 31. The prosthesisof claim 22, wherein the first segment further comprises an inflatableballoon.
 32. The prosthesis of claim 22, wherein the distal portion ofthe first segment further comprises a coudé tip.
 33. The prosthesis ofclaim 22, wherein the first and second segments comprise a biocompatiblematerial.
 34. The prosthesis of claim 33, wherein the biocompatiblematerial comprises silicone.
 35. The prosthesis of claim 22, furthercomprising a retrieval piece connected to the second segment.
 36. Theprosthesis of claim 35, wherein the retrieval piece comprises a thread.37. A method of draining bodily fluid from a patient having an externalsphincter situated for voluntary control over drainage of at least onebodily fluid, comprising the steps of: (1) inserting a prosthesis intothe urethra of a patient, the prosthesis comprising: (a) a first segmentincluding a distal portion and a proximal portion, the distal portioncomprising a distal opening, the proximal portion comprising a proximalopening, the first segment defining a lumen extending from the distalopening to the proximal opening; (b) a second segment connected to thefirst segment at an inter-segmental distance, the second segmentincluding a distal portion and a proximal portion, the distal portion ofthe second segment comprising a distal opening, the proximal portion ofthe second segment comprising a proximal opening, the second segmentdefining a lumen extending from the distal opening of the second segmentto the proximal opening of the second segment; and (c) an adjustable tieconnecting the proximal portion of the first segment and the distalportion of the second segment; and (2) adjusting the adjustable tie toadopt the one of a plurality of inter-segmental lengths, therebypositioning the first and second segments at one of a plurality ofinter-segmental distances, which allows or disallows insertion of anobject between the two segments wherein the insertion intercepts fluidcommunication between the lumens of the first and second segments,thereby allowing or disallowing voluntary control over drainage of theat least one bodily fluid through the lumens of the two segments. 38.The method of claim 37, wherein one of a plurality of inter-segmentaldistances allows or disallows operation of the patient's externalsphincter muscle.
 39. The method of claim 37, wherein step (2) comprisesshortening the inter-segmental length and thereby the inter-segmentaldistance to allow constant fluid communication between the lumens of thefirst and second segments, thereby disallowing the voluntary control.40. The method of claim 39, wherein step (2) comprises adjusting the tiesuch that the proximal portion of the first segment directly contactsthe distal portion of the second segment.
 41. The method of claim 37,wherein step (2) further comprises lengthening the inter-segmentallength and thereby the inter-segmental distance to allow the insertion,thereby allowing the voluntary control.
 42. The method of claim 37,wherein the adjustable tie forms at least one loop between the proximalportion of the first segment and the distal portion of the secondsegment.
 43. The method of claim 37, wherein the adjustable tiecomprises a thread with two ends and wherein step (2) comprises pullingboth ends of the thread.
 44. The method of claim 43, wherein the ends ofthe thread are connected at a knot and pulling both ends of the threadcomprises pulling the knot.
 45. The method of claim 37, wherein theprosthesis further comprises a retrieval piece connected to the secondsegment, and wherein step (2) comprises pulling the retrieval piecesubstantially away from the first segment.
 46. The method of claim 37,wherein the prosthesis further comprises a second tie also connectingthe proximal portion of the first segment with the distal portion of thesecond segment, the second tie having a predetermined inter-segmentallength between the first and the second segments; and wherein the methodfurther comprises lengthening the inter-segmental distance to allow theinsertion, the inter-segmental distance being limited by thepre-determined inter-segmental length of the second tie.
 47. The methodof claim 46, further comprising removing the adjustable tie from theurethra.
 48. The method of claim 37, further comprising surrounding thepatient's penis with a condom catheter for receiving the at least onebodily fluid.
 49. The method of claim 37, further comprising connectingthe prosthesis to a drainage bag to collect the at least one bodilyfluid passing through prosthesis.
 50. A method of draining bodily fluidfrom a patient having an external sphincter situated for voluntarycontrol over drainage of at least one bodily fluid, comprising the stepsof: (1) inserting a prosthesis into the urethra of a patient, theprosthesis comprising: (a) a first segment including a distal portionand a proximal portion, the distal portion comprising a distal opening,the proximal portion comprising a proximal opening, the first segmentdefining a lumen extending from the distal opening to the proximalopening; (b) a second segment connected to the first segment at aninter-segmental distance, the second segment including a distal portionand a proximal portion, the distal portion of the second segmentcomprising a distal opening, the proximal portion of the second segmentcomprising a proximal opening, the second segment defining a lumenextending from the distal opening of the second segment to the proximalopening of the second segment; (c) a first tie engaging the first andthe second segments by holding the segments in proximity to allow fluidcommunication between the lumens of the segments; and (d) a second tiehaving a pre-determined inter-segmental length between the first and thesecond segments; (2) constantly draining at least one bodily fluidthrough the lumens of the two segments held by the first tie; and (3)when voluntary control over fluid drainage is desired, disengaging thefirst tie such that the first tie no longer affects the inter-segmentaldistance, thereby relying on the second tie for connecting the twosegments at a predetermined inter-segmental distance sufficient forinsertion of an object between the two segments to intercept the fluiddrainage.
 51. The method of claim 50, wherein the pre-determinedinter-segmental distance permits operation of an external sphincter. 52.The method of claim 50, further comprising removing the disengaged firsttie from the urethra while retaining at least a portion of theprosthesis inside the urethra,
 53. The method of claim 50, wherein thefirst tie, before the disengagement, holds the proximal portion of thefirst segment in direct contact with the distal portion of the secondsegment.
 54. The method of claim 50, further comprising surrounding thepatient's penis with a condom catheter for receiving the at least onebodily fluid.
 55. The method of claim 50, further comprising connectingthe prosthesis to a drainage bag to collect the at least one bodilyfluid passing through the prosthesis.
 56. The method of claim 50,wherein the first tie comprises a loop connecting the first and secondsegment, a tape and an actuation thread, all connected at a junction,the tape comprises a perforated portion connected to the actuationthread at the junction, and the method further comprising pulling theactuation thread, thereby separating the perforated portion from thetape to disengage the first tie.
 57. The method of claim 50, wherein theprosthesis further comprises a retrieval piece attached to the secondsegment, and wherein step (3) further comprises pulling the retrievalpiece substantially away from the first segment.